XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 Asian Health
 Food & Nutrition
 Men's Health
 Mental Health
 Occupational Health
 Public Health
 Sleep Hygiene
 Women's Health
 Canada Healthcare
 China Healthcare
 India Healthcare
 New Zealand
 South Africa
 World Healthcare
   Latest Research
 Alternative Medicine
 Clinical Trials
 Infectious Diseases
  Brain Diseases
  Demyelinating Diseases
   Multiple Sclerosis
  Neurodegenerative Diseases
  Spinal Cord Diseases
  Trigeminal Neuralgia
 Sports Medicine
   Medical News
 Awards & Prizes
   Special Topics
 Odd Medical News

Last Updated: Nov 18, 2006 - 1:55:25 PM

Multiple Sclerosis Channel
subscribe to Multiple Sclerosis newsletter

Latest Research : Neurosciences : Demyelinating Diseases : Multiple Sclerosis

   DISCUSS   |   EMAIL   |   PRINT
Fampridine-SR in Phase 3 Trial for Multiple Sclerosis Under FDA Guidance
May 4, 2005 - 9:56:00 PM, Reviewed by: Dr.

"We are delighted to have reached this agreement with the FDA on the design of our pivotal study of Fampridine-SR in MS. We look forward to beginning the study as soon as possible."

Acorda Therapeutics announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment for a pivotal, Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). A Special Protocol Assessment (SPA) is a process in which the FDA provides evaluation and guidance on clinical trial protocols for Phase 3 studies.

"We are delighted to have reached this agreement with the FDA on the design of our pivotal study of Fampridine-SR in MS. We look forward to beginning the study as soon as possible," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics.

The primary outcome measure for the study will be an improvement in walking as measured by the Timed 25-Foot Walk and the MS Walking Scale-12 (MSWS12). Currently, there are no treatments available that improve walking in MS sufferers, and physicians and patients regularly rate walking as one of the areas of greatest unmet medical need for this condition. Secondary outcome measures for the study include the Lower Extremity Manual Muscle Test (LEMMT), a standardized, 5-point manual assessment of leg strength, as well as the Ashworth score for spasticity and global impressions.

MS is characterized by frequent waxing and waning of the patient's walking ability, strength and other neurological functions. The objective of the study will be to show that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo.

About Fampridine-SR

Fampridine-SR ("4-aminopyridine", "4-AP") is an investigational, sustained-release tablet formulation of 4-aminopyridine. It is being developed in human clinical trials for both MS and spinal cord injury (SCI). In laboratory studies fampridine has improved impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.

Results from the most recent Phase 2 MS clinical trial showed a positive trend for improvement in average walking speed (as measured by the Timed 25 Foot Walk) and a statistically significant improvement in LEMMT. A post-hoc analysis, using the methods to be applied in the Phase 3 study, showed a significant increase in the number of subjects with consistently improved walking speed in the Fampridine-SR treated group versus the placebo-treated subjects. These data are consistent with from the results of earlier Phase 2 trials.

Adverse events, including serious adverse events, seen in these studies were insomnia, paresthesias (numbness/tingling), dizziness and nausea, the majority of which were rated as mild to moderate. Seizure was reported in a small number of patients at higher doses than are currently being evaluated. As Fampridine-SR is an investigational drug, safety and efficacy have not been fully determined.

- U.S. Food and Drug Administration (FDA)


Subscribe to Multiple Sclerosis Newsletter
E-mail Address:


About Acorda Therapeutics

Acorda Therapeutics, a privately-held biotechnology company, is developing therapies for spinal cord injury (SCI), multiple sclerosis (MS) and related nervous system disorders. The Company's marketed products include ZANAFLEX(R)CAPSULES (tizanidine hydrochloride), a short-acting drug indicated for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda's lead clinical-stage product is Fampridine-SR, which is being developed for both MS and SCI. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.


Acorda Therapeutics
Tierney Saccavino, 914-347-4300 x104
[email protected]

Related Multiple Sclerosis News
Smoking associated with rapid progression of multiple sclerosis
Testosterone may help men with multiple sclerosis
Age of onset but not severity of Multiple Sclerosis inherited from parents
Cause of nerve fiber damage in multiple sclerosis identified
Fampridine may hold promise for treating Multiple Sclerosis
CNS can send out signals to invite autoimmune attacks
Natalizumab Re-approved for Relapsing Multiple Sclerosis
Efficacy in relapse rate reduction beyond five years shown for interferon beta 1b in Multiple Sclerosis
Systematic Review Questions Accuracy of MRI in Multiple Sclerosis
Statins could prove useful in treating MS

For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page


© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us